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Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck (NUTRIMAX)

Primary Purpose

Nutrition Disorders, Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental group
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients affected by a cancer of the VADS
  • Man or woman of 18 and more years old
  • Patient benefiting from a surgery for its cancer of the VADS
  • Patient having signed a written consent
  • Patient member in a national insurance scheme

Exclusion Criteria:

  • Patient minor
  • Patient benefiting from a radiotherapy
  • Patient participant in another research interfering on the nutritional state of the patient
  • Patients under guardianship or guardianship

Sites / Locations

  • CHU Amiens-PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in "better to eat". In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5. The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions.

The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP).

Outcomes

Primary Outcome Measures

The satisfactory nutritional state defined by the absence of loss of weight
weight loss difference equal to 0 between the time 0 and the 6th month

Secondary Outcome Measures

The score PG-SGA (index of Detsky)

Full Information

First Posted
July 16, 2018
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03632200
Brief Title
Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
Acronym
NUTRIMAX
Official Title
Improvement of the Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative. Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage. In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months. In the Group control, the patients will be followed according to the current recommendations of the SFNEP.
Detailed Description
Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative. Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage. In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months. In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders, Head and Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a pilot study to compare experimental group (improved coverage) and control group (classic coverage)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in "better to eat". In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5. The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP).
Intervention Type
Other
Intervention Name(s)
Experimental group
Other Intervention Name(s)
multidisciplinary specific consultation
Intervention Description
The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in "better to eat". In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5. The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions
Primary Outcome Measure Information:
Title
The satisfactory nutritional state defined by the absence of loss of weight
Description
weight loss difference equal to 0 between the time 0 and the 6th month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The score PG-SGA (index of Detsky)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients affected by a cancer of the VADS Man or woman of 18 and more years old Patient benefiting from a surgery for its cancer of the VADS Patient having signed a written consent Patient member in a national insurance scheme Exclusion Criteria: Patient minor Patient benefiting from a radiotherapy Patient participant in another research interfering on the nutritional state of the patient Patients under guardianship or guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dakpé, MD
Phone
+330322089080
Email
dakpe.stephanie@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Dakpé, MD
Organizational Affiliation
CHU Amiens Picardie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dakpé Stéphanie, MD

12. IPD Sharing Statement

Learn more about this trial

Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck

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